CPTS LTD

CONSUMER PRODUCTS TESTING SOLUTIONS

Consulting by CPTS covers all aspects of product safety compliance management.

Guidance to the beginning, middle, and end of a products life-cycle.
 

When you may need QA consulting:

Growing number of projects

Rapid company Growth

Quality decrease due to bottlenecks

 Adoption of new methodologies or practices

The California Office of Environment Health Hazard Assessment (OEHHA) proposed restrictions on the use of short-form Prop 65 warning labels

On January 8, 2021, the OEHHA promulgated a notice of proposed rulemaking to amend Article 6 of Title 27 of the California Code of Regulations. If enforced, the amendments may create a new compliance obligation to businesses selling products to consumers in the state of California by significantly limiting the use of short-form safe harbor warnings.
Public written comment period: until March 8, 2021

In 2016, new Article 6 Clear and Reasonable Warning regulations were adopted by OEHHA which included provisions for a short-form Prop 65 warning. However, as less label space was required and the identification of a specific Prop 65 listed chemical could be avoided, the short-form could be utilized in ways that went against the intention and purpose.

Since less information is provided to the consumer by the short-form warning, the January 8 proposal would restrict its use by suggesting various changes, including:

  • Limiting the use of the short-form warning for consumer information to products with 5 square inches or less of label space available (and where the package shape or size cannot accommodate the full-length warning). The requirement of type size of the warning remains unchanged (i.e., type size no smaller than “the largest type size used for other consumer information on the product” and no smaller than 6-point type)

  • Requiring identification of at least one Prop 65 listed chemical in the warning for which the warning is being provided

  • Prohibiting the short-form warning listed for internet purchases and catalog purchases even when the warning provided on the product itself is in compliance with the regulation

  • Including the words “Risk” and “Exposure” in the warning

  • Clarifying the use of short-form warnings for food including the use of an offset boxed warning

    • A short-form warning for exposures to chemicals in food is not clearly allowed in the current regulation. OEHHA has therefore proposed a new short-form warning be included for food of which the language is very similar to the one for other products.

Under the proposal, the new warning would be more detailed, providing more information.

Below is an example warning statement when the product requires a warning from both toxicity endpoints (carcinogen and reproductive toxicant):

“WARNING: Cancer Risk from [insert chemical name] and Reproductive Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”

The proposed amendments will be subject to a public written comment period that runs until March 8, 2021. A web-based public hearing will be scheduled, only upon request. Considering a strong opposition from the business community, OEHHA has proposed that the regulation become operative one year after the effective date of the amendments. Any products that are manufactured within that one-year window and that carry the current short-form warning may be sold through indefinitely. As a result, the new regulations would not apply to products manufactured prior to the enforcement date of the regulations.

The European Union (EU) revised the list for allergenic fragrance in toys

On December 15, 2020, the EU published two Directives (EU) 2020/2088 and (EU) 2020/2089 to revise the two lists of allergenic fragrances in the Toy Safety Directive, 2009/48/EC.
Effective date of Directives: July 5, 2022

The two Directives, (EU) 2020/2088 and (EU) 2020/2089, update the lists under Point 11 of Part III in Annex II of the Toy Safety Directive (TSD). These lists are:

  1. ‘Prohibited List’ – contains 55 allergenic fragrances. Their presence is allowed if it is technically unavoidable under good manufacturing practice (GMP) and each fragrance is no more than 100 mg/kg. These substances should not be used intentionally

  2. ‘Labelling List’ – contains 11 allergenic fragrances. These require their name to be listed on the toy, on an affixed label, on the packaging, or in the accompanying leaflet if their concentrations are greater than 100 mg/kg

Summary of the Amendment

List of allergenic fragrances which require labelling has been extended (from 11 to 71 allergenic fragrances)

  1. Added 61 allergenic fragrances

  2. Added 2 CAS no. to Citronellol (1117-61-9 and 7540-51-4)

  3. Removed methyl heptane carbonate (111-12-6), as it becomes a prohibited allergenic fragrance

List of prohibited allergenic fragrances has been extended (from 55 to 58 allergenic fragrances)

  1. Added 3 allergenic fragrances

Name of Allergenic Fragrances CAS Number:

Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde) 526-37-4

Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde) 57074-21-2

Methyl heptine carbonate 111-12-6

Textile Fiber Products Identification Act: FTC amends rules and regulations

The U.S. Federal Trade Commission (FTC) has amended the Rules & Regulations Under the Textile Fiber Products Identification Act to incorporate the latest ISO 2076 standard: ISO 2076:2013(E), “Textiles—Man-made fibres—Generic names.” This incorporation by reference will promote international consensus along with providing manufacturers selling textiles products in multiple countries with more flexibility in the labeling of textile products.

Section 303.7 of the Textile Fiber Products Identification Act establishes the generic names for manufactured fibers that must be used in the required fiber content disclosures by:

  • Listing the generic names and definitions the FTC has established through its textile petition process, and

  • Incorporating by reference the generic names and definitions set forth in the ISO 2076 standard (currently ISO 2076-2010(E) standard is incorporated by reference).

The amendment to incorporate by reference the ISO 2076:2013(E), allows the use of seven additional manufactured fibers, listed below, that were added to the standard in the revision from 2010 to 2013:

  1. “chitin,”

  2. “ceramic,”

  3. “polybenzimidazol,”

  4. “polycarbamide,”

  5. “polypropylene/polyamide bicomponent,”

  6. “protein,” and

  7. “trivinyl.”

The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of November 5, 2020.